Newgen Biotech USA Inc. is a contract manufacturer and biotechnology solutions provider based in Farmers Branch, Texas. Specializing in natural ingredient innovation, fermentation-based actives, and softgel manufacturing, the company serves the dietary supplement, functional food, cosmetic, and personal care industries globally. With vertically integrated operations and proprietary bioactive compounds, Newgen is a strategic partner for brands seeking turnkey product development, regulatory compliance, and cutting-edge science.
Company Background
Established in the United States as the North American arm of a globally integrated biotech group, Newgen Biotech USA Inc. leverages over two decades of scientific expertise in microbial fermentation, nutraceuticals, and wellness ingredients. With an operational headquarters in Texas and partner facilities in Asia, Newgen operates across R&D, custom formulation, GMP manufacturing, and distribution of specialty raw materials.
The company maintains an FDA-registered, cGMP-compliant softgel production facility, and offers contract services across encapsulation, tableting, blending, and ingredient standardization. Their in-house analytical lab ensures consistent product quality with full regulatory documentation.
Core Business
Newgen Biotech provides comprehensive solutions for:
- Fermented and naturally derived bioactives
- Contract manufacturing and softgel production
- Custom blending and formulation development
- Ingredient sourcing and distribution
- Analytical testing and regulatory consulting
Product & Service Offerings
Proprietary Bioactives
- BettHer® – Marine-derived beta-glucan complex used for immune and gut health formulations
- Betimmune™ – Patented beta-glucan standardized for immune modulation
- Enzyme Complexes – Fungal and bacterial enzyme blends for digestion, sports recovery, and skin health
- Probiotic Strains – High-viability species for gut, skin, and oral microbiome support
Contract Manufacturing Services
- Softgels – FDA-registered facility, capacity for multiple gelatin types (bovine, fish, vegan)
- Powder Blends – Custom nutraceutical or cosmetic ingredients
- Capsules/Tablets – Blister packs and bulk format available
- Packaging & Labeling – Shelf-ready units and fulfillment options
Ingredient Categories
- Marine-sourced bioactives
- Enzyme formulations
- Fermented probiotics and prebiotics
- Vitamins, amino acids, and botanical extracts
- Raw materials for cosmetics, personal care, functional food, and dietary supplements
Specialization and Unique Strengths
- Vertically Integrated Supply Chain: End-to-end from fermentation to final packaging
- GMP & FDA-Compliant: Production facility licensed and regularly audited
- Analytical Testing In-House: Includes HPLC, microbiology, stability testing
- Custom Formulation Expertise: Ability to co-develop products under private label
- Clinical Support: Ingredients backed by scientific literature and human trials
Financial Insights
Newgen Biotech USA Inc. is a privately held company. While financials are not publicly disclosed, the company's export and contract volume indicate:
- Estimated Annual Revenue: USD $25–40 million
- Production Volume:
- Over 120 million softgels/year
- Blending and capsule filling for 200+ SKUs annually
- Client Base: 100+ global brands and ingredient distributors
- Growth Rate: 15–20% YoY over the last five years (based on contract expansions)
Export and Shipment Records
- Active clients in North America, Latin America, Southeast Asia, and the EU
- FDA-registered facility for dietary supplements
- Regulatory documents available for global compliance: COA, MSDS, TDS, Allergen-Free, GMO-Free
- Ingredients listed with Health Canada, USP Monographs, and Pharmacopeial references
Target Market
- Nutraceutical Brands
- Functional Beverage Companies
- Skin and Personal Care Product Formulators
- Private Label Supplement Retailers
- Ingredient Distributors and Brokers
- Sports Nutrition and Digestive Health Companies
Capabilities
- Softgel Manufacturing: Gelatin and plant-based options with customized shell thickness and fill types
- Lab Services: Microbial ID, ingredient potency, dissolution profiling, heavy metals screening
- Custom Encapsulation: Liquid and semi-solid fills with emulsion or suspension support
- Stability Programs: Real-time and accelerated protocols
- Warehousing & Logistics: Climate-controlled inventory and drop shipping services
Certifications and Compliance
- FDA Registered – U.S. Food and Drug Administration
- cGMP Compliant – Current Good Manufacturing Practices
- Halal and Kosher Certified Softgel Lines
- NSF and ISO Standards (Partner Manufacturing Facilities)
- Allergen-Free, Gluten-Free, Non-GMO Verified Ingredients
- Regulatory documentation supporting GRAS, DSHEA, and NPN frameworks
Customer Testimonials
"Newgen’s marine beta-glucan helped us launch a clean-label immune product that outperformed our legacy SKUs. Their formulation and testing services are top-tier."
— Chief Innovation Officer, U.S. Functional Supplement Brand
"Reliable lead times and consistent softgel quality make Newgen an excellent partner. We scaled production twice with their team in under 18 months."
— Director of Operations, Canadian Nutraceutical Distributor
Achievements
- Launched BettHer®, one of the first marine-based beta-glucans approved for GRAS applications
- Developed over 250 private label formulations since 2019
- Recognized by industry publications for innovation in fermented bioactives
- Expanded softgel output by 80% between 2021–2023
- Supported successful FDA audits for several contract brand partners
